Guidance Documents for 2014
In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can...
View ArticleAffordable Breakthrough Innovations
Innovative ideas for medical devices are often costly for manufacturers to make and for patients to own. However, not all innovative medical devices will cost you an arm and a leg. Health Innovations...
View ArticlePre-Submission Program – Final Guidance
On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA...
View ArticleWarning Letters – Ten Tips
Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies...
View ArticleImplementing a Successful Recall Process – Ten Tips
In the medical device arena, recalls are a fact of life and competitors love to find out that you’ve had one. Regardless of recall classification (Class I, II, or III), a recall procedure is...
View ArticleCAPA – Best Practice Sharing
Healthy CAPAs = Competitive Advantage By now, we should all be familiar with the purpose of Corrective and Preventive Action (CAPA) as defined by the FDA Inspections guidelines: “The purpose of the...
View ArticleSuccessful Regulatory Strategy-Ten Tips
Having a documented regulatory strategy developed early during a new product’s development life cycle and updated periodically is critical for a new product’s market success. An inaccurate or lack of...
View Article510(k) Submissions-Ten Tips for a Successful Submission
The process of submitting a 510(k), demonstrating that your device is substantially equivalent to a device that is already cleared, can be daunting. Typically designed to be a 90-day review by the FDA,...
View ArticleTen Tips for Successful Integration of Risk Management & Usability Engineering
Even though Risk Management and Usability Engineering are clearly two separate processes with unique requirements, they are interdependent and must communicate with each other during the entire product...
View ArticleTen Tips for A Successful Use of Total Product Life Cycle (TPLC) Reports
The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). The intention behind this new report is to provide...
View ArticleGuidance Documents for 2014
In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can...
View ArticleAffordable Breakthrough Innovations
Innovative ideas for medical devices are often costly for manufacturers to make and for patients to own. However, not all innovative medical devices will cost you an arm and a leg. Health Innovations...
View ArticlePre-Submission Program – Final Guidance
On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA...
View ArticleWarning Letters – Ten Tips
Each year, the FDA issues hundreds of warning letters to medical device companies for reasons ranging from manufacturing practice violations to breaches in labeling and misbranding. Companies...
View ArticleImplementing a Successful Recall Process – Ten Tips
In the medical device arena, recalls are a fact of life and competitors love to find out that you’ve had one. Regardless of recall classification (Class I, II, or III), a recall procedure is...
View ArticleCAPA – Best Practice Sharing
Healthy CAPAs = Competitive Advantage By now, we should all be familiar with the purpose of Corrective and Preventive Action (CAPA) as defined by the FDA Inspections guidelines: “The purpose of the...
View ArticleSuccessful Regulatory Strategy-Ten Tips
Having a documented regulatory strategy developed early during a new product’s development life cycle and updated periodically is critical for a new product’s market success. An inaccurate or lack of...
View Article510(k) Submissions-Ten Tips for a Successful Submission
The process of submitting a 510(k), demonstrating that your device is substantially equivalent to a device that is already cleared, can be daunting. Typically designed to be a 90-day review by the FDA,...
View ArticleTen Tips for Successful Integration of Risk Management & Usability Engineering
Even though Risk Management and Usability Engineering are clearly two separate processes with unique requirements, they are interdependent and must communicate with each other during the entire product...
View ArticleTen Tips for A Successful Use of Total Product Life Cycle (TPLC) Reports
The FDA, as part of the transparency initiative, has developed a Total Product Life Cycle (TPLC) report capability on their website (www.fda.gov). The intention behind this new report is to provide...
View Article
